Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers: Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Fractal analysis
研究概览
简要总结
The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals.
详细描述
The study is planned as a randomized controlled clinical trial. The randomized controlled study will be conducted at the Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Endodontics, and will include adult volunteers who have been diagnosed with asymptomatic apical periodontitis, present periapical lesions with PAI scores of 2, 3, and 4, have an indication for root canal treatment, meet the inclusion criteria of the study, and have provided written informed consent.
Volunteers will be randomly selected from patients attending our clinic according to lesion size. A computer-assisted randomization method (www.randomizer.org) will be used. Root canal treatments will be completed using AH Plus or TotalFill BC root canal sealers.
The required sample size will consist of a total of 64 volunteers: 16 volunteers with PAI 2-3 scored teeth treated with AH Plus, 16 volunteers with PAI 4 scored teeth treated with AH Plus, 16 volunteers with PAI 2-3 scored teeth treated with TotalFill BC, and 16 volunteers with PAI 4 scored teeth treated with TotalFill BC.
After completion of the root canal treatments, postoperative radiographs will be obtained and follow-up will be performed at 6 months. Postoperative pain will be assessed at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as at 1 week following completion of the root canal treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The bioistatician performing the data analysis will be blinded to group allocation. The clinician performing the treatments will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy individuals aged between 18 and 60 years with no systemic diseases
- •Teeth with periapical lesions (apical periodontitis) that have not undergone previous root canal treatment
- •Single-rooted maxillary and mandibular teeth
- •Teeth with PAI scores of 2, 3, and 4 according to the PAI classification
- •Teeth without a sinus tract or acute apical abscess
- •Patients who voluntarily agree to participate in the study and attend follow-up visits
- •Teeth with sufficient remaining tooth structure to allow restoration with a direct restoration after root canal treatment -
排除标准
- •Patients who have used antibiotics, analgesics, or anti-inflammatory drugs within the last 7 days
- •Pregnant or breastfeeding patients
- •Patients with traumatic malocclusion
- •Patients without occlusal contact
- •Teeth with root resorption, open apices, or calcification
- •Teeth presenting gingival recession greater than 3 mm, deep periodontal pockets, or mobility
- •Teeth with root fractures or cracks
- •Presence of an adjacent tooth requiring endodontic treatment that may cause referred pain
- •Multirooted teeth
- •Teeth with a PAI score of 5
- •Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive loss of tooth structure after root canal treatment
- •Teeth with structural loss severe enough to require post-core application
- •Cases in which adequate anesthesia cannot be achieved with local anesthesia alone (requiring additional intrapulpal or intraligamentary anesthesia)
- •Teeth requiring active periodontal treatment
- •Individuals with severe systemic diseases
结局指标
主要结局
Fractal analysis
时间窗: 6. month
In this study, fractal analysis of each sample will be performed using the box-counting method.
VAS scala
时间窗: 6.,12.,24.,36.,48.,72. hours and 1 week
Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, on a form using the Visual Analog Scale (VAS). One week after treatment, volunteers will be contacted by telephone, and the pain scores indicated on the pain assessment forms will be obtained and recorded in the patient files.
次要结局
未报告次要终点
研究者
Neslihan Büşra Keskin
Assoc. Prof.
Ankara Yildirim Beyazıt University